Director of Clinical Operations

Director of Clinical Operations in biotech will be responsible for the strategic planning, execution, and management of clinical trials to ensure they meet company goals, budgets, and quality standards. Key responsibilities include overseeing trial sites, managing vendor relationships (like CROs), ensuring regulatory compliance.

Key responsibilities

• Clinical trial management: Lead and oversee the operational aspects of clinical development programs, from planning to execution and completion.
• Team and vendor leadership: Manage a team of clinical operations staff, and work with and manage external vendors, such as Contract Research Organizations (CROs).
• Budget management: Develop and manage the departmental and clinical trial budgets, which can involve negotiating vendor contracts and ensuring cost-effectiveness.
• Regulatory compliance: Ensure all clinical activities comply with regulatory requirements, including FDA and ICH guidelines, and manage the preparation of regulatory documents like INDs.
• Strategic planning: Contribute to the overall clinical development strategy, including scenario planning, timeline forecasting, and feasibility assessments.

Required qualifications

• Education: A Bachelor's degree in life sciences or a related field is typically required; advanced degrees are often preferred.
• Experience: A minimum of 10-15 years of clinical trial experience in the biotech or pharmaceutical industry
• Skills:
• Strong leadership and management skills.
• Exceptional strategic planning and problem-solving abilities.
• Deep knowledge of clinical trial management and regulatory compliance.
• Excellent communication, negotiation, and organizational skills.
• Experience with clinical trial management systems and international regulatory agencies is also beneficial.

Job Type: Full-time

Pay: $185,000.00 - $225,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: Remote